Active, Not Recruiting
An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors - CA224-020
Updated: 27 March, 2024 | ClinicalTrials.gov
Phase
Gender(s)
Age Range
Active, Not Recruiting
Inclusion Criteria: - For Dose escalation: subjects with cervical, ovarian, bladder and colorectal cancer (CRC), head and neck, gastric and hepatocellular cancer naive to immuno-oncology agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or without anti-CTLA-4. - For Dose Expansion: all of the above in escalation except for cervical, ovarian, and CRC - Progressed, or been intolerant to, at least one standard treatment regimen, except for participants in 1st line cohorts. - ECOG performance status between 0 and 2 - At least 1 lesion with measurable disease at baseline - Availability of an existing tumor biopsy sample (and consent to allow pre-treatment tumor biopsy) Exclusion Criteria: - Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the only site of active disease - Autoimmune disease - Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent - Uncontrolled CNS metastases Other protocol defined inclusion/exclusion criteria could apply
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